Når Nordnet allerede nu er største køber med over 6000 stk.
Er det private der køber? Nogen af jer herinde på ProInvestor?
Det ligner en klapjagt hvor GSI er klapper.
Er det private der køber? Nogen af jer herinde på ProInvestor?
Det ligner en klapjagt hvor GSI er klapper.
3/4 2009 10:47 jru 0
6854 Ja - lidt i 214,75. Med GSI har ikke været søde hverken i går eller i dag, men de er måske færdige.
Mon vi ikke skal se kursstigninger op mod luk - hvis vi ikke får en rar meddelelse før
Mon vi ikke skal se kursstigninger op mod luk - hvis vi ikke får en rar meddelelse før
3/4 2009 10:57 tumult 06856 GSI har stor repekt blandt de andre mæglere i Genmab aktien, så hvis der er nogen der gerne vil holde den nede, er det gennem dem de skal sælge.
Husk at Medarex sidst solgte gennem GSI.
Jeg synes den er meget deprimerende at have og hvor er vores milestones anyway?
Jeg synes den er meget deprimerende at have og hvor er vores milestones anyway?
3/4 2009 11:52 jru 06869 Hvis du synes den er deprimerende, så bør man måske begynde at være lidt bekymret. 
Milestones skal da nok komme - men hvormange 50 eller 100 mio.$, det kan måske blive problemer. Hvad forventer mankedet?
Et andet spørgsmål bliver vel nok om de får "priority review". Godt nok er kursen lav for øjeblikket, men hvis de ikke får der - Hvad så?
Jeg er absolut ikke negativ, men i denne verden må man have øjnene åbne for alle muligheder.-
Hvis alt går godt ser vi hurtigt en kurs over 250 - i et bedre marked på den anden side af 300
Milestones skal da nok komme - men hvormange 50 eller 100 mio.$, det kan måske blive problemer. Hvad forventer mankedet?
Et andet spørgsmål bliver vel nok om de får "priority review". Godt nok er kursen lav for øjeblikket, men hvis de ikke får der - Hvad så?
Jeg er absolut ikke negativ, men i denne verden må man have øjnene åbne for alle muligheder.-
Hvis alt går godt ser vi hurtigt en kurs over 250 - i et bedre marked på den anden side af 300
3/4 2009 13:04 collersteen 06878 4/3/2009 12:02:46 - OMX Copenhagen, News
Genmab A/S Company Announcement Arzerra™ (ofatumumab) Granted Priority Review by FDA
Summary: The US FDA has accepted the Biologics License Application for
ofatumumab.
Copenhagen, Denmark; April 3, 2009 - Genmab today announced that the US Food
and Drug Administration (FDA) has accepted the Biologics License Application
(BLA) for Arzerra(TM) (ofatumumab) to treat patients whose chronic lymphocytic
leukemia (CLL) is resistant (refractory) to previous therapies and has granted
ofatumumab priority review status.
Under priority review, the FDA sets the target date for a decision from
regulators at six months, rather than the standard 10 month review. If
approved, ofatumumab would be the first monoclonal antibody targeted to CD20
available for this patient population. In addition, the FDA has granted
ofatumumab orphan designation for the treatment of CLL. The BLA was submitted
on January 30, 2009.
“We are pleased that the ofatumumab BLA has been accepted for review by the FDA
and look forward to the outcome of the review process,” said Lisa N. Drakeman,
Ph.D., Chief Executive Officer of Genmab.
The acceptance of the BLA will trigger a milestone payment from GSK to Genmab
of DKK 87 million (approximately $15 million). In addition, Genmab will also
receive a one-time payment of $4.5 million from GSK in exchange for terminating
its option to co-promote Arzerra(TM). In December 2008, GSK and Genmab amended
their initial agreement and GSK now has exclusive global commercialization
rights to Arzerra for all potential indic
ations.
About ofatumumab
Ofatumumab is a novel, investigational, fully human monoclonal antibody that
targets a membrane-proximal (close to the cell surface) small loop epitope (a
portion of a molecule to which an antibody binds) on the CD20 molecule of
B-cells. This epitope is different from the binding sites targeted by other
CD20 antibodies currently available. The CD20 molecule is a key target in CLL
therapy because it is expressed on most B-cells in CLL patients.
Ofatumumab is being developed under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline. It is not yet approved in any
country.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery, development and manufacturing teams are using
cutting-edge technology to create and develop products to address unmet medical
needs. Our primary goal is to improve the lives of patients who are in urgent
need of new treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.
This Stock Exchange Release contains forward looking statements. The words
“believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed o
r implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
product discovery and development, uncertainties related to the outcome and
conduct of clinical trials including unforeseen safety issues, uncertainties
related to product manufacturing, the lack of market acceptance of our
products, our inability to manage growth, the competitive environment in
relation to our business area and markets, our inability to attract and retain
suitably qualified personnel, the unenforceability or lack of protection of our
patents and proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our products obsolete,
and other factors. For a further discussion of these risks, please refer to the
section “Risk Management” in Genmab's Annual Report, which is available on
www.genmab.com. Genmab does not undertake any obligation to update or revise
forward looking statements in this Stock Exchange Release nor to confirm such
statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R);
HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
HuMax-CD32b(TM); HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM) and UniBody(R)
are all trademarks of Genmab A/S. Arzerra(TM) is a trademark of
GlaxoSmithKline.
Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: [email protected]
Stock Exchange Release no. 12/2009
###
See attachment: https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=219672
Genmab A/S Company Announcement Arzerra™ (ofatumumab) Granted Priority Review by FDA
Summary: The US FDA has accepted the Biologics License Application for
ofatumumab.
Copenhagen, Denmark; April 3, 2009 - Genmab today announced that the US Food
and Drug Administration (FDA) has accepted the Biologics License Application
(BLA) for Arzerra(TM) (ofatumumab) to treat patients whose chronic lymphocytic
leukemia (CLL) is resistant (refractory) to previous therapies and has granted
ofatumumab priority review status.
Under priority review, the FDA sets the target date for a decision from
regulators at six months, rather than the standard 10 month review. If
approved, ofatumumab would be the first monoclonal antibody targeted to CD20
available for this patient population. In addition, the FDA has granted
ofatumumab orphan designation for the treatment of CLL. The BLA was submitted
on January 30, 2009.
“We are pleased that the ofatumumab BLA has been accepted for review by the FDA
and look forward to the outcome of the review process,” said Lisa N. Drakeman,
Ph.D., Chief Executive Officer of Genmab.
The acceptance of the BLA will trigger a milestone payment from GSK to Genmab
of DKK 87 million (approximately $15 million). In addition, Genmab will also
receive a one-time payment of $4.5 million from GSK in exchange for terminating
its option to co-promote Arzerra(TM). In December 2008, GSK and Genmab amended
their initial agreement and GSK now has exclusive global commercialization
rights to Arzerra for all potential indic
ations.
About ofatumumab
Ofatumumab is a novel, investigational, fully human monoclonal antibody that
targets a membrane-proximal (close to the cell surface) small loop epitope (a
portion of a molecule to which an antibody binds) on the CD20 molecule of
B-cells. This epitope is different from the binding sites targeted by other
CD20 antibodies currently available. The CD20 molecule is a key target in CLL
therapy because it is expressed on most B-cells in CLL patients.
Ofatumumab is being developed under a co-development and commercialization
agreement between Genmab and GlaxoSmithKline. It is not yet approved in any
country.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery, development and manufacturing teams are using
cutting-edge technology to create and develop products to address unmet medical
needs. Our primary goal is to improve the lives of patients who are in urgent
need of new treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.
This Stock Exchange Release contains forward looking statements. The words
“believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed o
r implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
product discovery and development, uncertainties related to the outcome and
conduct of clinical trials including unforeseen safety issues, uncertainties
related to product manufacturing, the lack of market acceptance of our
products, our inability to manage growth, the competitive environment in
relation to our business area and markets, our inability to attract and retain
suitably qualified personnel, the unenforceability or lack of protection of our
patents and proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our products obsolete,
and other factors. For a further discussion of these risks, please refer to the
section “Risk Management” in Genmab's Annual Report, which is available on
www.genmab.com. Genmab does not undertake any obligation to update or revise
forward looking statements in this Stock Exchange Release nor to confirm such
statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R);
HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
HuMax-CD32b(TM); HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM) and UniBody(R)
are all trademarks of Genmab A/S. Arzerra(TM) is a trademark of
GlaxoSmithKline.
Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: [email protected]
Stock Exchange Release no. 12/2009
###
See attachment: https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=219672
Solsen, jeg mener vi har et problem nu med at regne os frem til 169 mill preapproval milestones. Hvad skulle i de næste 4 måneder kunne udløse så mange penge (som ikke er udskudt?)?
3/4 2009 13:25 Solsen 06882 Ingen ide om hvor de skulle komme fra andet end de så ligger i NHL-fase 3, som jo er en betydelig større indikation end CLL.
Sikken et gætteri !
Nå men vi sætter uret til den 30/7 2009 !!!!!!!!!!!
Men der er lang tid til.
Sikken et gætteri !
Nå men vi sætter uret til den 30/7 2009 !!!!!!!!!!!
Men der er lang tid til.
3/4 2009 13:26 Stinker 06883 Hvad skal man mon lægge i det forhold, at overdragelsen af co-markedsføringsretten tilsyneladende var betinget af ansøgningens accept?
"In addition, Genmab will also receive a one-time payment of $4.5 million from GSK in exchange for terminating its option to co-promote Arzerra(TM). In December 2008, GSK and Genmab amended their initial agreement and GSK now has exclusive global commercialization
rights to Arzerra for all potential indic ations."
Kan det tænkes at accepten - i modsætning til den fremherskende opfattelse her på sitet - alligevel indgår i puslespillet om en eventuel overtagelse af Genmab?
"In addition, Genmab will also receive a one-time payment of $4.5 million from GSK in exchange for terminating its option to co-promote Arzerra(TM). In December 2008, GSK and Genmab amended their initial agreement and GSK now has exclusive global commercialization
rights to Arzerra for all potential indic ations."
Kan det tænkes at accepten - i modsætning til den fremherskende opfattelse her på sitet - alligevel indgår i puslespillet om en eventuel overtagelse af Genmab?
3/4 2009 13:40 tumult 06884 Ikke umuligt.
Der er lagt "flydespæring" ud i 230, mon de fremstormende masser tager den med sig.?
Der er lagt "flydespæring" ud i 230, mon de fremstormende masser tager den med sig.?
Hvormeget præmie skal man have for at tage risiko i Biotek. Temmeligt meget. Faktisk så meget at vi nu er på niveauet for introkurs for 10 år siden.
10 år med usikkerhed om pipeline, risiko for stop af produkter, patientbivirkninger og funding usikkerheder. 10 år hvor vel en ud af 7 (troldmanden har sikkert statistikken
) biotek firmaer er gået ned. 10 år hvor næsten HELE den danske bioteksektor er totalt udslettet. Vi har vel kun en håndfuld tilbage der har en chance.
Hvad skal investorerne have for efter 10 år at have fundet et selskab der efter succesfuldpartnering, solid pipeline og 4 måneder fra et potentielt produkt på markedet.
Svaret er: glæden ved at risikere sin investering. Et stort 0 % efter 10 år. Det er imponerende. Lagerbeskatning intet problem - vælg biotek......
Det er faneme uhyggeligt....
10 år med usikkerhed om pipeline, risiko for stop af produkter, patientbivirkninger og funding usikkerheder. 10 år hvor vel en ud af 7 (troldmanden har sikkert statistikken
) biotek firmaer er gået ned. 10 år hvor næsten HELE den danske bioteksektor er totalt udslettet. Vi har vel kun en håndfuld tilbage der har en chance. Hvad skal investorerne have for efter 10 år at have fundet et selskab der efter succesfuldpartnering, solid pipeline og 4 måneder fra et potentielt produkt på markedet.
Svaret er: glæden ved at risikere sin investering. Et stort 0 % efter 10 år. Det er imponerende. Lagerbeskatning intet problem - vælg biotek......
Det er faneme uhyggeligt....
3/4 2009 13:47 JørgenVarnæs 06888 ja - er det ikke fantastisk. Unoterede biotekaktier vil blive lagerbeskattet uden mulighed for carry back - og beskatningsgrundlaget er indre værdi.
Den "investeringsmulighed" vil der ikke være en eneste investor til...
Den "investeringsmulighed" vil der ikke være en eneste investor til...
men med Mike Legarth´s udødelige ord (han er konservativ, ikke kommunist)
"Hvis man ikke har råd til skatten, kan man jo bare sælge aktierne"
"Hvis man ikke har råd til skatten, kan man jo bare sælge aktierne"
3/4 2009 13:54 JørgenVarnæs 06891 det er næsten så langt fra den virkelige verden, som det kan være. Gad vide om han er kunde i Lundbeck´s kerneforretning?
NEJ! Men det bliver vi! Så mon ikke han er sælger for dem?
3/4 2009 15:24 Sukkeralf 06916 Dog er markedsværdien siden introduktionen fordoblet - ikke at det er alverden med den fremgang
Mvh
Sukkeralf
Mvh
Sukkeralf
3/4 2009 15:48 troldmanden 06921 Hej Sukkeralf
Et stort velkommen til. Hvor er det fedt at se dig herinde!
Det har været en hård enmands kamp for mig at holde genmab drengene i stand så er glad for at min gæve partner nu også har fundet frem til tasteturet ....
Vh
T.
Et stort velkommen til. Hvor er det fedt at se dig herinde!
Det har været en hård enmands kamp for mig at holde genmab drengene i stand så er glad for at min gæve partner nu også har fundet frem til tasteturet ....
Vh
T.
Sukkeralf, dit modspil er savnet, mit mismod stort. Jeg har dem stadig...og Ingen vrister mine genmab fra mig efter 7 år
Rigtig glad for at se dit første indlæg....
Rigtig glad for at se dit første indlæg....
3/4 2009 17:47 tumult 06934 også et stort "velkommen" fra mig til sukkeralf.
GSI der normalt køre med klatten, vikre lidt klundtet i dag.
De har solgt 35000 stk til kurs 222 og købt 38000 stk til kurs 227 ?
Det virker som om de er desperate for at forbedre deres gennemsnits kurs.
GSI der normalt køre med klatten, vikre lidt klundtet i dag.
De har solgt 35000 stk til kurs 222 og købt 38000 stk til kurs 227 ?
Det virker som om de er desperate for at forbedre deres gennemsnits kurs.
3/4 2009 13:51 Solsen 06889 Genmab fraskrev sig retten til at co-promote Ofatumumab omkring årsskiftet 2008/09 og fik lovning på 4,5 mln USD, når acceptance forelå - helt som aftalt.
3/4 2009 14:00 Stinker 06894 Men Solsen, det kan vel ikke være således, at det kun var betalingen, der var betinget af accept? Overdragelsen må da tilsvarende have været betinget.
3/4 2009 14:08 Solsen 06898 Jo sikkert - men GSK havde nok kun givet Genmab co-promote så længe de var en selvstændig virksomhed uden nogen der havde aktiemajotet
Derfor er vi ude i hypotetiske diskussioner
GSK var i en fyringsrunde da de sikkert pressede Genmab til at tage stilling - derfor får Genmab 4,5 mil USD for at tage stilligt tidligere end BLA ansøgningen.
I øvrigt ville Genmab nok næppe have brugt retten alligevel, idet deres udrensning af stoffer reducerede deres muligheder for at blive et rigtigt pharmaselskab
Derfor er vi ude i hypotetiske diskussioner
GSK var i en fyringsrunde da de sikkert pressede Genmab til at tage stilling - derfor får Genmab 4,5 mil USD for at tage stilligt tidligere end BLA ansøgningen.
I øvrigt ville Genmab nok næppe have brugt retten alligevel, idet deres udrensning af stoffer reducerede deres muligheder for at blive et rigtigt pharmaselskab
3/4 2009 14:12 Stinker 06902 OK - du mener at co-markedsføringsretten alligevel automatisk ville være faldet tilbage til GSK i tilfælde af trediemands overtagelse af Genmab. Så er min spekulation selvfølgelig ikke aktuel.
3/4 2009 14:09 Stinker 06899 Blot for lige at opridse overvejelsen:
Værdien af co-markedsføringsretten ligger - antager jeg - først og fremmest i at andre ikke får tag i den. Hvis overdragelsen af retten faktsik var betinget af accept, er det dermed nærliggende at antage at accept indgår som en betingelse i en tredieparts eventuelle overtagelse Genmab.
Værdien af co-markedsføringsretten ligger - antager jeg - først og fremmest i at andre ikke får tag i den. Hvis overdragelsen af retten faktsik var betinget af accept, er det dermed nærliggende at antage at accept indgår som en betingelse i en tredieparts eventuelle overtagelse Genmab.
Med mere positive briller....hvorfor gives PR:
Priority (P) review — Preliminary estimates indicate that the drug product, if approved,
has the potential to provide, in the treatment, prevention, or diagnosis of a disease, one of
the following: (1) safe and effective therapy where no satisfactory alternative therapy
exists; or (2) a significant improvement compared to marketed products (approved, if
approval is required), including nondrug products or therapies. Significant improvement
is illustrated by the following examples: (1) evidence of increased effectiveness in
treatment, prevention, or diagnosis of disease; (2) elimination or substantial reduction of
a treatment-limiting drug reaction; (3) documented enhancement of patient compliance;
or (4) evidence of safety and effectiveness in a new subpopulation. Although such
evidence can come from clinical trials directly comparing a marketed product with the
investigational drug, a priority designation can be based on other scientifically valid
information.
A priority designation is intended to direct overall attention and resources to the
evaluation of applications for drug products that have the potential for providing a
significant improvement in the treatment, prevention, or diagnosis of a disease when
compared to standard applications.
Priority (P) review — Preliminary estimates indicate that the drug product, if approved,
has the potential to provide, in the treatment, prevention, or diagnosis of a disease, one of
the following: (1) safe and effective therapy where no satisfactory alternative therapy
exists; or (2) a significant improvement compared to marketed products (approved, if
approval is required), including nondrug products or therapies. Significant improvement
is illustrated by the following examples: (1) evidence of increased effectiveness in
treatment, prevention, or diagnosis of disease; (2) elimination or substantial reduction of
a treatment-limiting drug reaction; (3) documented enhancement of patient compliance;
or (4) evidence of safety and effectiveness in a new subpopulation. Although such
evidence can come from clinical trials directly comparing a marketed product with the
investigational drug, a priority designation can be based on other scientifically valid
information.
A priority designation is intended to direct overall attention and resources to the
evaluation of applications for drug products that have the potential for providing a
significant improvement in the treatment, prevention, or diagnosis of a disease when
compared to standard applications.
